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Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

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ClinicalTrials.gov Identifier: NCT02175680
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.

Brief Summary:

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.

Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.


Condition or disease Intervention/treatment Phase
HIV Human Immunodeficiency Virus Drug: PRO 140 350mg weekly SQ injection. Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection
Study Start Date : May 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
Drug: PRO 140 350mg weekly SQ injection.
CCR5 Antagonist




Primary Outcome Measures :
  1. Time to Virologic Failure after initiating PRO 140 monotherapy. Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. [ Time Frame: 14 Weeks ]

Secondary Outcome Measures :
  1. Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. [ Time Frame: 14 Weeks ]
  2. Mean change in Viral Load (HIV-1 RNA levels), at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
  3. Mean change in Viral Load (HIV-1 RNA levels), within the 14-week treatment phase [ Time Frame: 14 Weeks ]
  4. Mean change in CD4 cell count, at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
  5. Mean change in CD4 cell count, within the 14-week treatment phase [ Time Frame: 14 Weeks ]

Other Outcome Measures:
  1. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: 14 Weeks ]
  2. Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: 14 Weeks ]
  3. Frequency of Treatment-emergent serious adverse events [ Time Frame: 14 Weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay
  3. On stable antiretroviral therapy for last 12 months
  4. Subject has two or more potential alternative antiretroviral regimen options to consider.
  5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12 months prior to Screening Visit
  6. Nadir CD4 cell count of >200 cells/mm3

Exclusion Criteria:

  1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit
  2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
  3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
  4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140.
  5. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175680


Locations
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United States, California
Quest Clinical Research
San Francisco, California, United States, 94115
Sponsors and Collaborators
CytoDyn, Inc.
Investigators
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Principal Investigator: Jacob Lalezari, MD

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Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT02175680     History of Changes
Other Study ID Numbers: PRO 140_CD 01
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016

Keywords provided by CytoDyn, Inc.:
HIV-1
HIV
Treatment Substitution
PRO 140
PRO140
CytoDyn
Amarex

Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
PRO-140 monoclonal antibody
HIV Antibodies
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs